Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00624858
Eligibility Criteria:
Inclusion Criteria:
* Female and male subjects must be 18 to 65 years of age;
* Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;
* Meet criteria for major depression
* Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
* Able to comply with all required study procedures and schedule;
* Able to speak and read English;
* Willing and able to give written informed consent
Exclusion Criteria:
* Obesity of known endocrine origin
* Serious medical condition
* History of drug or alcohol abuse or dependence
* Use of excluded concomitant medications
* History of surgical or device (e.g. gastric banding) intervention for obesity;
* History or predisposition to seizures
* Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
* Planned surgical procedure that can impact the conduct of the study;
* Use of investigational drug, device or procedure within 30 days prior to Screening;
* Participation in any previous clinical trial conducted by Orexigen Therapeutics;
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00624858
Study Brief:
Protocol Section:
NCT00624858